MDR and IVDR updates: what changes for in vitro diagnostic and medical device manufacturers?

published on 20 February 2025 | reading time approx. 4 minutes

Medical devices ("MDs") and in vitro diagnostic medical devices ("IVDs") are regulated by Regulation (EU) 2017/745 ("MDR") and (EU) 2017/746 ("IVDR"), respectively. These regulations repealed and replaced Directives 93/42/EEC, 90/385/EEC, 98/79/EC.

However, the transition to the new regulatory framework has proven challenging, primarly due to the small number of notified bodies accredited to assess device conformity under the new standards and the non-completion of the digital infrastructure EUDAMED, the European medical device database which is intended to replace individual national databases.

To curb these problems and avoid the disruption of the supply of medical devices on the EU market, the legislator decided to amend the MDR and the IVDR.

The amendments introduced by Regulation (EU) 2024/1860 concern:

new information obligations for manufacturers;
changes to the implementation of EUDAMED;
modification of the transitional periods for in vitro diagnostic medical devices.

Let us look at them individually.

Information obligations in the event of interruption or termination of supply

As of 10 January 2025, in the event of an interruption or termination of supply of DMs and IVDs that could result in serious harm to patients or public health, manufacturers must promptly inform the entities they supply (e.g. their distributors or supplied healthcare institutions) and the competent authorities of the Member State where the manufacturer or its authorized representative is located.

This information obligation applies to all devices placed on the EU market, including legacy devices (MDs and IVDs compliant with the repealed directives that can still be placed on the market under the transitional period established by the MDR and IVDR).

Unless they are prevented from doing so (e.g. in cases of natural disasters or sudden shortages of raw materials), manufacturers are obliged to give notice of the interruption or the discontinuation of supply by means of the Manufacturer Information Form (see MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices) at least six months in advance of the intended interruption or discontinuation.

Using EUDAMED

The way the European Database for Medical Devices (EUDAMED) is currently being implemented has also been changed.

EUDAMED is divided into modules, each dedicated to tracking data on different aspects of the sector (module for registering economic operators, devices, surveillance, etc.). The previous legislation established that the use of EUDAMED would only become mandatory once all modules were declared operational by the Commission.

Given the delay in the implementation of some modules, to avoid unduly delaying the compulsory use of EUDAMED, the legislator has now established that the modules will also become compulsory individually, again following a specific communication from the Commission.

The Commission estimates that the modules for the registration of economic operators, devices, notified/certified bodies and market surveillance could become mandatory in the first half of 2026.

Extension of transitional periods for legacy in vitro diagnostic medical devices

Legacy in-vitro diagnostic medical devices are IVDs that comply with the previous Directive 98/79/EC and that can continue to be placed on the market, provided they meet certain requirements imposed by the IVDR.

Under certain conditions, the amendments extended the possibility of placing on the market legacy devices that were subject to a conformity assessment procedure by a notified body under the previous directive until 31 December 2027.

Similarly, legacy devices that, under the previous directive, were not subject to the conformity assessment procedure by a notified body (i.e. only subject to the declaration of conformity) but are subject to the IVDR may, under certain conditions, continue to be placed on the market until:

31 December 2027 for Class D devices;
31 December 2028 for Class C devices;
31 December 2029 for class B devices and A sterile devices.

Conclusions

The changes to the MDR and the IVDR mainly affect manufacturers. Among the main novelties are the information obligations in case of interruption or termination of supply of devices, the gradual implementation of the EUDAMED platform and the extended transition periods for in vitro diagnostic medical devices. Given the current complexity of the regulatory framework, economic operators are advised to:

verify whether the devices they market are subject to information obligations in the event of discontinuation;
stay up-to-date on the status of the implementation of EUDAMED;
for IVDs, check whether the conditions for benefiting from the transitional period are met.

Among the various activities of the practice, Rödl & Partner provides specialized and interdisciplinary support to companies in their MDR compliance verification processes, in order to minimize the risk of sanctions or disputes by the competent authorities for companies in the sector, also in view of the particular complexity of the regulations.